Traduction de «community preventive medicine physician » (Anglais → Français) :

EUROPA - EU law and publications - EUR-Lex - EUR-Lex - 32011L0062 - EN - Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products Text with EEA relevance // DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF T ...[+++]HE COUNCIL // of 8 June 2011 // (Text with EEA relevance)

Insofar as advanced therapy products are presented as having properties for treating or preventing diseases in human beings, or that they may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting principally a pharmacological, immunological or metabolic action, they are biological medicinal products within the meaning of Annex I to Directive 2001/83/EC of th ...[+++]e European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use , read in conjunction with the definition of medicinal products in Article 1(2) thereof.

The categories concerned should be medicinal products which aim at the treatment, prevention or medical diagnosis of seriously debilitating or life-threatening diseases, or medicinal products to be used in emergency situations in response to public health threats recognised either by the World Health Organisation or by the Community in the framework of Decision No 2119/98/EC of the European Parliament and of the Council of 24 Septe ...[+++]mber 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community (3), or medicinal products designated as orphan medicinal products in accordance with Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (4).

When a medicinal product has been authorised at Community level [49] the marketing authorisation issued in accordance with Regulation 2309/93 relates to the specific packaging prescribed for the medicinal product in the application for authorisation. The authorisation determines the pack sizes and the immediate packaging to be used for the medicinal product, as well as the information to be included on the immediate or outer packaging [50]. The Court has held that the detailed and specific requirements regarding the packaging, which are in ...[+++]tended to prevent consumers from being misled and, thereby, to protect public health preclude the joining together and re-labelling of packages of that medicinal product [51]. The Court added, however, that the creation of new packaging may be possible if that repackaging is objectively necessary [52] so that the imported product gains effective access to the market of a Member State.

(8) experience in the United States of America and Japan shows that the strongest incentive for industry to invest in the development and marketing of orphan medicinal products is where there is a prospect of obtaining market exclusivity for a certain number of years during which part of the investment might be recovered; data protection under Article 4(8)(a)(iii) of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(4) is not a sufficient incentive for that purpose; Member States acting independently cannot introduce such a measure ...[+++]without a Community dimension as such a provision would be contradictory to Directive 65/65/EEC; if such measures were adopted in an uncoordinated manner by the Member States, this would create obstacles to intra-Community trade, leading to distortions of competition and running counter to the single market; market exclusivity should however be limited to the therapeutic indication for which orphan medicinal product designation has been obtained, without prejudice to existing intellectual property rights; in the interest of patients, the market exclusivity granted to an orphan medicinal product should not prevent the marketing of a similar medicinal product which could be of significant benefit to those affected by the condition;

For the purpose of establishing, pursuant to the second subparagraph of Article 3(1)(a) of Regulation (EC) No 141/2000, that a medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Community, and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return t ...[+++]o justify the necesary investment, the following specific rules shall apply and the appropriate documentation shall be provided in accordance with the guidance drawn up pursuant to Article 5(3) of Regulation (EC) No 141/2000: